Trial Condition(s):
Healthy Volunteers
Copanlisib Mass Balance Study
Bayer Identifier:
16353
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Study Completed
Trial Purpose
The study aims to provide understanding of the relative relevance of the different excretion pathways of Copanlisib in humans, as well as to characterize its metabolite profile.
Inclusion Criteria
- Healthy male subject - Age: 45 to 65 years - Body weight greater or equal to 60 kg and body mass index (BMI): above/equal 18 and below/equal 30 kg/m²
Exclusion Criteria
- Regular use of medicines - Known recent (last 2 years) abuse of recreational drugs, suspicion of drug or alcohol abuse, or positive results of the drug and alcohol screen tests at screening or baseline - Use of strong inhibitors of cytochrome P450 (CYP)3A4, as well as use of St John’s Wort or strong inducers of CYP3A4 prohibited from 14 days before the administration of study drug until discharge from the clinic - Smoking - Average intake of more than 24 units of alcohol per week; Regular daily consumption of more than 1 L of methylxanthine-containing beverages - Any condition, which may result in longer than usual retention of urine or feces in the body, such as pronounced (less than one defecation in 2 days) constipation or symptomatic prostatic hypertrophy. - Participation in another mass balance study with a radiation burden > 0.1 mSv in the period of 1 year before screening
Trial Summary
Enrollment Goal
6
Trial Dates
Phase
1
Could I receive a placebo?
No
Products
Aliqopa (Copanlisib, BAY80-6946)
Accepts Healthy Volunteers
Yes
Where to Participate
Loading...
Locations
| Locations | |
|---|---|
Locations Pharma Bio-Research Zuidlaren, Netherlands, 9471 GP | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Single center, open-label, non-randomized, non-placebo-controlled study to investigate the metabolism, excretion pattern, mass balance, safety, tolerability and pharmacokinetics after single intravenous administration of 12 mg [14C]Copanlisib (BAY 80-6946) in healthy male subjects
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Basic Science
Allocation:
N/A
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Pharmacokinetics of copanlisib in plasma by maximum concentration (Cmax)Timeframe: Multiple time points up to 336 hours
- Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve from the first time point (t=0) extrapolated to infinity (AUC)Timeframe: Multiple time points up to 336 hours
- Pharmacokinetics of copanlisib in plasma by area under the measured matrix concentration versus time curve to the last data point above the lower limit of quantitation (AUC(0-tlast))Timeframe: Multiple time points up to 336 hours
- Pharmacokinetics of total radioactivity in plasma by CmaxTimeframe: Multiple time points up to 336 hours
- Pharmacokinetics of total radioactivity in plasma by AUCTimeframe: Multiple time points up to 336 hours
- Pharmacokinetics of total radioactivity in plasma by AUC(0-tlast)Timeframe: Multiple time points up to 336 hours
- Pharmacokinetics of total radioactivity in whole blood by CmaxTimeframe: Multiple time points up to 336 hours
- Pharmacokinetics of total radioactivity in whole blood by AUCTimeframe: Multiple time points up to 336 hours
- Pharmacokinetics of total radioactivity in whole blood by AUC(0-tlast)Timeframe: Multiple time points up to 336 hours
- Radioactivity excreted in urine as a percentage of the dose (AE,ur)Timeframe: Multiple time points up to 336 hours
- Radioactivity excreted in feces as a percentage of the dose (AE,fec)Timeframe: Multiple time points up to 336 hours
- Metabolite profile in plasmaTimeframe: Multiple time points up to 336 hours
- Metabolite profile in urineTimeframe: Multiple time points up to 336 hours
- Metabolite profile in fecesTimeframe: Multiple time points up to 336 hours
Secondary Outcome
- Number of participants with adverse events as a measure of safety and tolerabilityTimeframe: Until 30 days after study drug administration
Additional Information
Copyright © Bayer
Powered by
